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A REVIEW: NOVEL SUPERDISINTEGRANTS
Ashok Dalimbe1, Jaydeep Pawar2*, Shital Bhosale3, Nikita Shinde4, Rushikesh tupe5
Department Of Pharmaceutics, HSBPVT's GOI College of Pharmacy (Affiliated to Savitribai Phule Pune
University), Kashti, Dist. Ahmednagar, 414701, Maharashtra, India.
Abstract
Fast dissolving, fast melting, chewable and orally dissolving or disintegrating tablets are solid dosage forms
that disintegrate rapidly and dissolve in the mouth without water. These products have staying power in the
marketplace because they appeal to consumers and support increased compliance among users as well as
provide effective life-cycle management. The principle challenge with mouth dissolving tablet (MDT) is to
develop tablet formulations that deliver rapid disintegration, pleasant mouth feel and high breaking force for
tablet robustness. Superdisintegrants affect a range of formulation parameters; including the rate of
disintegration, tablet breaking force, and mouth feel, superdisintegrant provides optimal performance in
MDT formulations.
Key Words: Superdisintegrants, mouth dissolving tablet (MDT), Disintegrants, Swelling, Deformation etc.
Introduction
Tablet disintegration has received considerable attention as an essential step in obtaining fast drug release.
The emphasis on the availability of drug highlights the importance of the relatively rapid disintegration of a
tablet as a criterion for ensuring uninhibited drug dissolution behavior.[1] Disintegrants are substances or
mixture of substances added to the drug formulations, which facilitate dispersion or breakup of tablets and
contents of capsules into smaller particles for quick dissolution. Superdisintegrants, are those substances,
which facilitate the faster disintegration with smaller quantity in contrast to disintegrants. The
disintegration of dosage forms are depends upon various physical factors of
disintegrants/superdisintegrants which are as follow:
1. Percentage of disintegrants present in the formulation.
2. Proportion of disintegrants used.
3. Compatibility with other excipients.
4. Presence of surfactants.
5. Hardness of the tablets.
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6. Nature of Drug substances.
7. Mixing and types of addition. [2, 3]
Researchers these days are looking for a new, safe and effective disintegrating agents which can disintegrate
tablets rapidly even at a tablet crushing strength of greater than 3.5 Kg. On analyzing the behavior of
disintegration time in the oral cavity as well as wetting time by surface free energy we came to know, that
for a faster wetting a molecule should have high polar component of surface free energy and the agents which
meet these special requirements are called as superdisintegrants. [4] The ease of availability of these agents
and the simplicity in the direct compression process suggest that their use would be a more profitable
alternative in the preparation of ODT than the sophisticated and patented techniques. [5]
Superdisintegrants are another version of super-absorbing materials with tailor-made swelling properties.
These materials are not planned to absorb significant amounts of water or aqueous fluids, but planned to
swell very fast. Superdisintegrants are used as a structural weakener for the disintegrable solid dosage forms.
They are physically dispersed within the matrix of the dosage form and will expand when the dosage form
is exposed to the wet environment. [6]These newer substances are more effective at lower concentrations
with greater disintegrating efficiency and mechanical strength.[7]Superdisintegrants are generally used at a
low level in the solid dosage form, typically 1 - 10 % by weight relative to the total weight of the dosage
unit. [8]Their particles are generally small and porous, which allow for rapid tablet disintegration in the
mouth without an objectionable mouth-feel from either large particles or gelling. The particles are also
compressible which improves tablet hardness and its friability.[6] Effective superdisintegrants provide
improved compressibility, compatibility and have no negative impact on the mechanical strength of
formulations containing high-dose drugs.[9]
Advantages of Superdisintegrants 15, 16, 17
Remarkable tendency on wetting causing rapid disintegration.
No lump formation on disintegration.
Compatible with commonly used therapeutic agents and excipients.
Does not stick to the punches and dyes.
Effective in lower concentrations.
Less effect on compressibility and flow ability.
More effective intragranularly.
Some are anionic and may cause some slight in vitro binding with cationic drugs.
Biodegradable.
Disadvantages of Superdisintegrants
Expensive.
Time consuming and fragile.
More sensitive and hygroscopic in nature.
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IDEAL PROPERTIES OF SUPERDISINTEGRANTS 17, 19, 20, 21
It should produce rapid disintegration.
It should produce good moulding and flow property.
It should have good particle size, good hydration capacity and compressibility index.
It should have poor water solubility.
It should produce compactable less friable tablets.
Effective at very low concentration and should have greater disintegrating efficiency.
Nontoxic and should have good mouth feel.
It should have no tendency to form complexes with the drugs.
It should be compatible with the other excipients and should have desirable tableting properties.
Mechanism of Action of Superdisintegrants
There are five major mechanisms for tablet disintegration as follows:-
1. Swelling
2. Porosity and Capillary Action (Wicking)
3. Deformation
4. Enzymatic reaction
5. Due to disintegrating particle/particle repulsive forces
1 Swelling
Swelling is believed to be a mechanism in which certain disintegrating agents (such as starch) impart the
disintegrating effect. By swelling in contact with water, theadhesiveness of other ingredients in a tablet is
overcome causing the tablet to fall apart. [10]
E.g. Sodium starch glycolate, PlatagoOvata. [11, 12, 13] (Fig.1)
Figure 1 Disintegration by Swelling
2. Porosity and Capillary Action (Wicking)
Effective disintegrants that do not swell are believed to impart their disintegrating action through porosity
and capillary action. Tablet porosity provides pathways for the penetration of fluid into tablets. The
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disintegrant particles (with low cohesiveness & compressibility) themselves act to enhance porosity and
provide these pathways into the tablet. Liquid is drawn up or “wicked” into these pathways through
capillary action and rupture the interparticulate bonds causing the tablet to break apart.E.g.Crospovidone,
Croscarmellose Sodium. [14] (Fig.2)
Figure 2 Disintegration by Wicking
3. Deformation
Starch grains are generally thought to be “elastic” in nature meaning that grains that are deformed under
pressure will return to their original shape when that pressure is removed. But, with the compression forces
involved in tableting, these grains are believed to be deformed more permanently and are said to be
“energy rich” with this energy being released upon exposure to water. In other words, the ability for starch
to swell is higher in “energy rich” starch grains than it is for starch grains that have not been deformed
under pressure. [15] (Fig.3)
Figure 3 Disintegration by Deformation
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4. By Enzymatic Reaction
Enzymes present in the body also act as disintegrants. These enzymes dearth the binding action of binder
and helps in disintegration. Due to swelling, pressure is exerted in the outer direction that causes the tablet
to burst or the accelerated absorption of water leads to an enormous increase in the volume of granules to
promote disintegration. [16] (Fig. 4)
Figure 4 Disintegration by Enzymatic Reaction
5. Due to disintegrating particle/particle repulsive forces
Another mechanism of disintegration attempts to explain the swelling of tablet made with “nonswellable”
disintegrants. Guyot-Hermann has proposed a particle repulsion theory based on the observation that
nonswelling particle also cause disintegration of tablets. The electric repulsive forces between particles are
the mechanism of disintegration and water is required for it. Researchers found that repulsion is secondary
to wicking. It is believed that no single mechanism is responsible for the action of most disintegrants. But
rather, it is more likely the result of inter-relationships between these major mechanisms. [17](Fig.5)
Figure 5 Disintegration by Repulsion
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Types of Superdisintegrants
The Superdisintegrants can be classified into two categories on the basis of their availability:
1. Natural Superdisintegrants
2. Synthetic Superdisintegrants.
1. Natural Superdisintegrants
These superdisinegrating agents are natural in origin and are preferred over synthetic substances because
they are comparatively cheaper, abundantly available, non-irritating and nontoxic in nature. The natural
materials like gums and mucilages have been extensively used in the field of drug delivery for their easy
availability, cost effectiveness, Eco friendliness, emollient and non-irritant nature, non-toxicity, capable of
multitude of chemical modifications, potentially degradable and compatible due to natural origin. There are
several gums and mucilages are available which have superdisintegrating activity. [18]
2. Soy polysaccharide
It is a natural super disintegrant that does not contain any starch or sugar so can be used in nutritional
products. Soy polysaccharide (a group of high molecular weight polysaccharides obtained from soy
beans) as a disintegrant in tablets made by direct compression using lactose and dicalcium phosphate
dihydrate as fillers. A cross-linked sodium carboxy-methyl cellulose and corn starch were used as
control disintegrants. Parameters studied were compressibility, friability and disintegration times.
Dissolution studies were conducted on tablets containing hydrochlorothiazide as a model drug of
low water solubility. Soy polysacchardie performs well as a disintegrating agent in direct
compression formulations with results paralleling those of cross-linked CMC at the 2% level and
superior to corn starch at the 8% level. Dissolution rates of the drug from tablets were rapid,
particularly at the 5% level and were not adversely affected by aging at room temperatures.
2. Isapghula Husk Mucilage (Plantago ovata)
Isapghula Husk consists of dried seeds of the plant known as plantago ovata. The plant contains
mucilage in the epidermis of the seeds. Mucilage of plantago ovata has various characteristics like
binding, disintegrating and sustaining properties. Mucilage can be used as superdisintegrant to
formulate fast dissolving tablets because it has very high percentage of swelling index (around
89±2.2%v/v) as compared to the other superdisintegrating agents. The rapid disintegration of the
FDTs is due to the swelling of superdisintegrants to create enough hydrodynamic pressure for quick
and complete disintegration of the tablet. The rate at which swelling develops and significant force of
swelling also determine its disintegrating efficiency. [19, 20]
3. Chitosan
Chitosan is a natural polymer obtained by deacetylation of chitin which is the second most abundant
polysaccharides in nature after cellulose. Superdisintegrant property of chitosan has been utilized to
develop a fast mouth dissolving tablet by utilizing a novel method of treatment. Similar to the other
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superdisintegrants chitosan too generously engulf water when in contact with aqueous media and
burst due to the pressure exerted by their capillary action thereby impart instantaneous disintegration
of the dosage form and resulting in formation of a uniform dispersion in the surrounding media
which behave like a true suspension formed inside the body leading to rapid and complete absorption
of drug. [21]
4. Guar Gums
Guar gum is naturally occurring guar seed extract, containing about 80% of galactomannan (guaran),
10% moisture, 5-7% protein and trace amounts of heavy metals and ash. It is free flowing,
completely soluble, neutral polymer and is approved for use in food. It is not sensitive to pH,
moisture contents or solubility of the tablet matrix. It is not always pure white and sometimes varies
in color from off-white to tan tends to discolour with time in alkaline tablets. As a disintegrant, guar
gum has been found to be superior to some common disintegrants such as corn starch, celluloses,
alginates and magnesium aluminium silicate. Particle size can affect disintegration, with finer particle
sizes having greater disintegrating capabilities. It is available in the market under the trade name
jaguar. [22, 23]
5. Agar
Agar is the dried gelatinous substance obtained from Gelidium amansii (Gelidanceae) and several
other species of red algae like, Gracilaria (Gracilariaceae) and Pterocadia (Gelidaceae). Agar is
yellowish gray or white to nearly colorless, odorless with mucilaginous taste and is accessible in the
form of strips, sheet flakes or coarse powder. Agar consists of two polysaccharides as agarose and
agaropectin. Agarose is responsible for gel strength and Agaropectin is responsible for the viscosity
of agar solutions. It is a potential candidate to act as a disintegrant due to its high gel strength. Gums
are used in concentration from 1 to 10%. However, these are not as good disintegrating agents as
others because capacity development is relatively low. [24]
2 Synthetic Superdisintegrants
A group of superdisintegrants including Croscarmellose sodium (Ac-Di-Sol), sodium starch glycolate
(Primogel, Explotab) and crospovidone (Polyplasdone XL) alleviate most of these problems. Use of the
superdisintegrants in fast dispersible tablet is possible as tablet shows optimum physical properties. [25]
Advantages of Synthetic Superdisintegrants
1 Effective in lower concentrations than starch.
2 Less effect on compressibility and flow ability.
3 More effective intragranularly. [26]
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Limitations of Synthetic Superdisintegrants
1 More hygroscopic (may be a problem with moisture sensitive drugs)
2 Some are anionic and may cause some slight in-vitro binding with cationic drugs (not a problem in-
vivo). [27]
3 An acidic medium significantly reduces the liquid uptake rate and capacity of sodium starch glycolate and
croscarmellose sodium, but not crospovidone. [28, 29]
3. The degree of swelling of Primogel (sodium starch glycolate) and Polyplasdone XL101
(crospovidone) is minimized following wet granulation formulation. Finally, the medium ionic
strength was found to have an adverse effect on the swelling capacity of croscarmellose. [30, 31]
1. INDION 414
The INDION 414 has been used as a superdisintegrant for ODT. It is chemically cross-linked polyacrylic,
with a functional group of – COO – and the standard ionic form is K+ and is a weak acid cationic exchange
resin. It has a high water uptake capacity. It is a high purity pharmaceutical grade weak acid cation exchange
resin supplied as a dry powder. It is an extremely effective superdisintegrant which provides the necessary
hardness and chemical stability to the tablet. The product swells up to a very great extend when in contact
with water or gastrointestinal fluids causing rapid disintegration without the formation of lumps. It is a high
molecular weight polymer, therefore it is not absorbed by the human tissues and totally safe for human
consumption.
The advantages of Indion 414 as a tablet disintegrant include remarkable swelling tendency on wetting, thus
causing rapid disintegration; there is no lump formation on disintegration; and it is compatible with
commonly used therapeutic agents and excipients. Indion 414 does not stick to punches and dies.
2. KYRON T-314
KYRON T-314 is “Polacrilin Potassium” which confirms to USP/NF specifications.It is derived from
crosslinked polycarboxylic acids and has K+ ionic form. It is a very high purity polymer used in
pharmaceutical formulations as a tablet super-disintegrant in the oral dosage formulations.
KYRON T-314 is used as:
As Disintegrating agent: Kyron T-314 has a very high swelling tendency of hydration either in contact with
water or G.I. fluids causing fast disintegration without the formation of lumps and thus acts as an effective
tablet super disintegrant. Required quantity is from 0.5% to 4.0% to get fast disintegration.
As Dissolution Improver: Kyron T-314 breaks the tablets into very smaller particles, thus it increases the
effective surface area for the absorption of the active substances and thus it increases the dissolution and
bioavailability of the active substances. Required quantity is from 2.0% to 6.0% for dissolution improvement.
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Advantages of Kyron T-314 are:
Super rapid Disintegration.Direct compressible grade.Elimination of lump formation.Compatibility with
other therapeutic agents-Imparts excellent strength to the tablet and also eliminates the sticking to the dyes
and punch.Only 0.4 to 2.0% quantity required.Swelling Index 12. (Cross PVP and Cross carmellose are of
Swelling Index 7 and 9 respectively.)
Toxicity: KYRON range is high molecular weight polymer so doesn’t get absorbed by body tissues and
safe for human consumption. It has no Physiological action at recommended dosage. It is non-toxic.
3. Starch Glutamate: Modified Potato Starch
Superdisintegrants have been developed to improve the disintegration process of the fast dissolving
tablets. Superdisintegrants acts as structural weaker in fast dissolving tablets and helps in the quick
breakup of the tablet into small particles. A new novel superdisintegrant starch glutamate has been
synthesized by esterification process. It was free flowing, amorphous in nature, having good swelling
index, excellent flow property.
4. Starch Oxalate
Starch oxalate as a novel superdisintegrant in fast dissolving tablet. Oxalic acid, a strong dicarbonic
acid mainly come from starch, was used to esterify gelatinized corn starch under nonaqueous conditions
to give a material with degrees of substitution (DS) ranging from 0.08 to 0.87 depending on the oxalic
acid/starch molar ratios used.
5. Starch tartrate
Starch tartrate as novel superdisintegrant by chemical modification of starch upon treating with tartaric
acid. More particularly application of this polymer in the design and development of fast disintegrating
tablets. The starch tartrate a novel polymer by modification of starch treating with tartaric acid at
elevated temperatures.
6. Starch-urea
Cross-linked starch-urea polymer was synthesized by gelatinization of starch in the presence of urea
and crosslinking by treatment with calcium chloride. starch-urea-citrate could be used as an
excellent super disintegrant.
Cross linked starch - urea, a new starch based polymer has been synthesized and its application in
controlled release Cross-linked starch-urea polymer was synthesized by gelatinization of starch in the
presence of urea and crosslinking by treatment with calcium chloride. Starch (9 parts) was dispersed
in purified water (10 parts) to form starch slurry. Urea (1 part) and calcium chloride (1 part) were
dissolved in purified water (40 parts) and the solution was heated to boiling. While boiling, the starch
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slurry was added and mixed. Mixing while heating was continued for 20 minutes to form cross-linked
starchurea polymer. The mass formed was spread on to a stainless steel plate and dried at 850C for 6-
8h. The dried polymer was powdered and passed through mesh No.100.
7. Starch Xanthates
Water‐insoluble starch xanthates were prepared by xanthation of highly crosslinked starches under
various conditions. After isolation of the products by solvent. Starch xanthate use as a superdisintegrant
in the formulation of fast dissolving tablets of poorly soluble drugs.
It is possible to synthesize sodium starch Xanthates from a wide range of native starches, but in practice
potato starch is used as it gives the product with the best disintegrating properties. After selection of
the appropriate starch source the second step is the crosslinking of the potato starch. This is typically
carried out using an FDA approved starch esterifying agent such as sodium trimetaphosphate or
phosphorus oxychloride in alkaline suspension. The effect of introduction of the large hydrophilic
carboxymethyl groups is to disrupt the hydrogen bonding within the polymer structure. This allows
water to penetrate the molecule and the polymer becomes cold water soluble. The effect of the
crosslinking is to reduce both the water soluble fraction of the polymer and the viscosity of dispersion
in water. The optimum balance between the degree of substitution and the extent of cross-linking
allows for rapid water uptake by the polymer without the formation of a viscous gel that might impede
dissolution.
8. Crospovidone
Unlike other superdisintegrants, which rely principally on swelling for disintegration, crospovidone
use a combination of swelling and wicking. Due to its high crosslink density, crospovidone swells
rapidly in water without gelling. Crospovidone particles are found to be granular and highly porous
which facilitates wicking of liquid into the tablet and particles to generate rapid
disintegration. [32]Larger particles provide a faster disintegration than smaller
particles. [33] Crospovidone disintegrants are highly compressible materials as a result of their unique
particle morphology. [32]Crospovidone can also be used as solubility enhancer. It is available in two
particle sizes in the form of Polyplasdone XL and Polyplasdone XL-10.
9. Croscarmellose Sodium
It is an internally cross linked polymer of carboxymethyl cellulose sodium. It has high swelling
capacity with minimal gellingresulting in rapid disintegration. [32] Due to fibrous structure,
croscarmellose particles also show wicking action. [35] In tablet formulations, croscarmellose
sodium may be used in both direct compression and wet-granulation processes. When used in wet-
granulation, the croscarmellose sodium should be added in both the wet and dry stages of the process
(intra- and extra-granularly) so that the wicking and swelling ability of the disintegrant is best
utilized. [34, 35]
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10. Sodium Starch Glycolate
Sodium Starch Glycolate is the sodium salt of a carboxymethyl ether of starch. These are modified
starches made by crosslinking of potato starch as it gives the product with the best disintegrating
properties. [37] The degree of cross-linking and substitution are important factors in determining the
effectiveness of these materials as superdisintegrants.[36]The effect of the crosslinking is to reduce
both the water soluble fraction of the polymer and the viscosity of dispersion in water. The natural
predried starches swell in water to the extent of 10-20 percent and the modified starches increase in
volume by 200-300 percent in water. The mechanism by which this action takes place involves rapid
absorption of water leading to an enormous increase in volume of granules that result in rapid and
uniform disintegration. These are available as explotab and primogel which are low substituted
carboxy methyl starches. [22]The effect of introduction of the large hydrophilic carboxymethyl
groups is to disrupt the hydrogen bonding within the polymer structure. This allows water to
penetrate the molecule and the polymer becomes cold water soluble. [36]
Method of Incorporation of superdisintegrants
The incorporation of superdisintegrants in the dosage forms are mainly of three types:
1 Intragranular or during granulation
In this process the superdisintegrants are blend with other powders and granulation is carried out. Thus the
superdisintegrants are incorporated within the granules.
2 Extragranular or prior to compression
In this process, the superdisintegrants are mixed with prepared granules before compression.
3 Incorporation of superdisintegrants at intra and extra granulation steps
In this process part of superdisintegrants are added to intragranular and a part to extragranules. This method
usually produces better results and more complete disintegration than type 1 and type 2. [38]
Applications of Superdisintegrants:
Superdisintegrant used in:
1. Pharmaceutical superdisintegrant: Superdisintegrants which provide improved compressibility
compared to prior art superdisintegrants. The superdisintegrants include a particulate agglomerate of
coprocessed starch or cellulose and a sufficient amount of an augmenting agent to increase the compactibility
of the superdisintegrant.
2. Rapidly disintegrating enzyme-containing solid oral dosage compositions: Invention relates to rapidly
disintegrating solid oral dosage forms having an effective amount of an enzyme and a superdisintegrant. The
enzyme lactase is claimed in this patent for solid oral formulations.
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3. Fast disintegrating tablets: A fast disintegrating tablet comprising Nimesulide and one or more
disintegrants. In this research superdisintegrants used are croscarmellose cellulose, crospovidone and sodium
starch glycolate.
4. Method of producing fast dissolving tablets: A method of producing a fast-melt tablet. The process
does not involve any granulation step, thereby making the process more energy efficient and cost effective.
The fast dissolving sugar alcohol is selected from the group comprising: mannitol; sorbitol; erythritol; xylitol;
lactose; dextrose; and sucrose. The active component is suitably provided in the form of microparticles or
microcapsules having an average diameter of less than 125 microns.
5. Disintegrating Loadable Tablets: A disintegrating loadable tablet product in compressed form. A
disintegrant or a mixture of disintegrants has a) porosity of 45% v/v or more, b) a hardness of at least 20
Newton, and c) a loading capacity of at least 30% of a liquid.
6. Rapidly disintegrating tablet: The study relates to rapidly disintegrating tablets intended to be used as
orodispersible tablets or dispersible tablets. The tablets include silicified microsrystalline cellulose. They are
especially suitable for antibiotics. Rapidly disintegrating tablets which contain amoxicillin and clavulanic
acid are also described.
7. Superdisintegrants provide rapid disintegration in oral solid dosage formulations. With its unique particle
morphology, Polyplasdone crospovidone is the disintegrant of choice in the following applications:
In wet granulation tablet processes, polymer, with it’s small average particle size, is highly effective
at rapid disintegration when used intragranularly.
Polyplasdone disintegrants are highly compressible, thus they are ideally suited for use with poorly
compressible drug actives and in direct compression tablet processes.
As Polyplasdone polymers are non-ionic, they will not form complexes with ionic drug actives that
would slow drug release. Recent data show Polyplasdone disintegrants provide fastest dissolution
with cationic drug actives in a model tablet formulation. 35
Polyplasdone XL-10 disintegrant is well suited for orally disintegrating and chewable tablet
formulations. It provides rapid disintegration, smooth mouth feel and high tablet breaking force with
low friability. 36
With poorly soluble drugs, Polyplasdone XL-10 crospovidone increases the rate and extent of
dissolution. 37
Conclusion
Now a days Fast Dissolving Tablets have a broader market in Pharmaceutical Industry. FDT’S are mostly
used for its fast dissolution and thus by fast absorption and at last immediate action which can be only
achieved by using superdisintegrants. The present article revealed about superdisintegrants and their
important in pharmaceutical Industry.
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